Dockets

Anti-Counterfeit Drug Initiative Workshop and Vendor Display (New 6/1/06)

Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding their Preferences for Public Health Notifications (New 6/8/06)

Agency Emergency Processing Under OMB Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (New 5/25/06)

Revise FDA's guidance entitled labeling for combined oral contraeceptives so that the labels of combined oral contraceptives have warnings relating to the risk of thromboembolic disease (New 7/25/2006)

Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets) (Updated 7/31/2006)

Dietary Supplement VI-28 TM Clarifying, in Writing, Whether or not the Dietary Supplement , as Detailed in the Pre-market Notification Filed 18 August 2005 (New 7/10/06)

Establish Criteria, Analogous to the Criteria for Marketing Category I Drug Products under OTC Drug Review Regarding the Substitutability of Prescription Hyoscyamine Drug Products (New 6/27/06)

Laser Light Show (New 12/28/05)

Food Allergen Labeling Notification (FALN): Starter Growth Media, Soy (Updated 6/8/06)

Require Manufacturers to Stop Using Xylene, Toluene, and Dibutyl phthalate in Nail Polish Marketed for Children Under the Age of 14 (New 12/21/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey (New 8/10/06)

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting (New 5/25/06)

Withdraw Draft Regulation on Mercury Amalgam (Updated 10/27/05)

Remove Metered-dose Inhalers (MDI) Containing the Single Active Moieties Beclomethasone, Fluticasone, and Salmeterol, Respectively, from the Essential-use List of Ozone-depleting Substance (New 12/7/05)

Requesting that the Commissioner of Food and Drugs Recommend Scheduling of Tramadol under the Controlled Substances Act (Updated 7/3/06)

Initiate a Transfer of Regulatory and Classification Responsibilities over Mercury Amalgam (Updated 10/27/05)

Laser Light Show (New 12/5/05)

Change in Dosage Form from Capsules to Tablets of Altace (ramipril) Capsules, 1.25 mg, 2.5 mg, 5 mg and 10 mg (New 12/7/05)

To Enforce Ban on Carbon Monoxide Gas in Fresh Meat Packaging (Updated 9/19/06)

Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired (Updated 10/18/06)

Determine that the Discontinued Formulation Zosyn (Piperacillin and Tazobactam for Injection), was not Discontinued for Safety and Efficacy Reasons (Updated 8/14/06)

FDA to Establish Tighter Regulations Governing the Process by which Medical Devices are Reviewed and Recalled (New 9/13/06)

To deny approval of Smith & Nephew's premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA (Update 06/07/2006)

Laser Light Show (New 11/14/05)

NDA 21-863, Ibuprofen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd. (Updated 5/10/06)

Food Allergen Labeling Notification (FALN): Extensively Hydrollyzed Casein (Updated 6/8/06)

Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512 (New 11/15/05)

Ban all non-medical uses of Triclosan, also known as Irgasan (Updated 01/24/07)

Reclassification of P990016 McCue CUBA Clinical Ultrasonic Bone Sonometry System (Updated 6/29/06)

Re-evaluate thePrescribing Info/Package Insert for New Tramadol and Tramadol as Schedule III Drugs under the Controlled Substances Act of 1970,as Amended (New 11/15/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation (New 4/19/06)

Immediately Add a Black Box Warning Regarding the Risks of Drug-induced Blindness for the Three Phosphodiesterase 5 Inhibitors that are Prescribed for the Treatment of Erectile Dysfuntion (Updated 7/27/06)

Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (New 4/19/06)

To Re-evaluate the Prescribing Information/Package Insert for NewTramdol Formulations in Light of Currently Available Safety Information (New 11/15/05)

Establish Therapeutic Equivalence Requirements for any Generic or Following-on Drug Product Referencing Adderall XR MASP (Updated 4/26/06)

Dextroamphetamine Sulfate Tablets, 2.5 mg,7.5 mg,15 mg,20 mg and 30 mg are Suitable for Submission as an ANDA (New 11/15/05)

Determination of ANDAs for Tretinoin Cream in the Intermediate 0.0375% and 0.075% Strengths (Updated 5/23/07)

Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein (Updated 6/8/06)

Performance Standard for Fluoroscopic Equipment Mfged by OrthoScan (New 11/14/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys (Updated 6/15/06)

Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments (Udated 1/3/06)

Seeking FDA Actions to counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs that Endanger Public Health (Updated 1/9/08)

Prescription Drug User Fee Act (PDUFA): Public Meeting (Updated 12/29/05)

Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray (Updated 6/13/06)

Declaration of Efavirenz Tablets for Oral Suspension 50 mg, 100 mg and 200 mg (New 11/15/05)

Make a Determination that Benzphetamine Hydrochloirde Capsule, 50 mg Drug Product is Suitable for Submission as an ANDA (Updated 07/24/06)

Reclassification for Metal/Metal Semiconstrained Hip Joint Prostheses with Cemented or Uncemented Acetabular Components (Updated 10/2/07)

Solicitation of Public Review and Comment on Research Protocol:Gonadotropin-releasing Hormone (GnRH) Agonist Test in Disorders of Puberty (Updated 12/12/05)

Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness." (Updated 4/24/06)

Permission to Donna Ricks to Continue Using Palladone for Severe Chronic Pain Due to Stage 4 Metastic Breast Cancer which has Spread to Lungs, Bones, and Liver (Updated 5/31/06)

ANDA Suitability for Carboplatin Injection, 10 mg/mL in a 1000 mg/100 mL Multiple-dose Vial (Updated 11/16/05)

Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA (New 5/25/06)

FDAs Communication of Drug Safety Information; Public Hearing (Updated 1/18/06)

Refuse to Approve any ANDA for Generic Oral Products Containing Oxandrolone until the Expiration od that Exclusitity Peroid on June 20, 2008 (Updated 1/12/07)

Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives (Updated 5/10/06)

Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing (New 8/24/07)

Stakeholder Meeting on the Implementation of a New Direction for Radiological Health Program; Public Meeting (Updated 12/13/05)

Projector for a Laser Light Show Phoenix: F4-1005 (New 10/5/05)

Projector for a Laser Light Show Goliath: G0-0704 (New 10/5/05)

Projector for a Laser Light Show Gizmo: G1-0504; Grendel: G2-0904 (New 10/5/05)

Projector for a Laser Light Show Gozer: G3-0405; Gryphon: G4-0905 (New 10/5/05)

Projectot for a Laser Light Show for Flare F1-1104; Flint: F2-0104; Firefly : F3-0905 (New 10/5/05)

Classification of the Low Energy Ultrasound Wound Cleaner (New 8/24/07)

Laser Light Show (New 11/8/05)

Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting (Updated 07/06/06)

Variance Request for a Performance Standand for a Radiographic Systems (New 10/5/05)

FDA Should Not Approve ANDA or NDA Under 505(b)(2) ('505(b)(2) NDAs) for Salmon Calcitonin Products Unless Certain Conditions Are Met (Updated 5/10/06)

Revocation of Status of Specific Products; Group A Streptococcus (Updated 12/27/05)

Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing (Updated 12/30/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Development Study (New 10/5/05)

Require that Standard Bioequivalence Criteria be Applied Separately to Oxybutynin and its Active Metabolite, Desethyloxbutynin, to Ensure that Approved Generic Versions of DITROPAN XL are both Equivalent and Clinicaly Equivalent to the Innovator Product (New 11/21/06)

Agency Information Collection Activities; Reclassification Petitions for Medical Devices (New 10/5/05)

FDA Survey of Current Manufacturing Practices in the Food Industry (New 10/5/05)

Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order (New 10/4/05)

Drug Approvals: Circumstances under which an Active Ingredient may be Simultaneously Marketed in both a Prescription Drug Product and an Over-the-Counter Drug Product (Updated 11/2/05)

Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006 (New 12/29/05)

Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment (Updated 12/29/05)

Laser Light Show (New 10/6/05)

Projector for a Laser Light Show (New 11/8/05)

Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods (New 1/3/06)

Designation of New Animal Drugs for Minor Uses or Minor Species (Updated 12/29/05)

P030004 - Onyx Liquid Embolic System (LES) (New 8/31/05)

Projector for a Laser Light Show (New 8/30/05)

Request Commissioner of Food and Drugs to Amend its Regulations Related to Sugar and Alternative Sweeteners (Updated 5/25/06)

Immediately Deny Approval of the NDA for INCRE (New 9/9/05)

P040021 - SJM Biocor Valve and SJM Biocor Supra Valve (New 8/30/05)

P040043 - GORE TAG Thoracic Endoprosthesis (New 8/30/05)

Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg Tablets (New 8/11/06)

Laser Light Show (New 11/8/05)

Laser Light Show (New 11/8/05)

Laser Light Show (New 11/14/05)

Guidance for Industry on Gene Therapy Clinical Trials Observing Participants for Delayed Adverse Events (New 12/28/05)

Laser Light Show (New 11/14/05)

Laser Light Show (New 11/14/05)

Remove Dietary Supplements that Contain the Drug Pyridoxamine (Updated 06/13/06)

CIBA Vision Corporation, Filing of CAP 5C0280; Safe Use of C.I. Pigment Violet 19, C.I. Pigment Yellow 154, and C.I. Pigment Red 122 as Color Additives in Contact Lenses (New 8/31/05)

CIBA Vision Corporation, Filing of Color Additive Petition 5C0279 C.I. Pigment Violet 19, C.I. Pigment Yellow 154, and C.I. Pigment Red 122 as Color Additives in Contact Lenses (New 8/31/05)

CIBA Vision Corporation; Filing of Color Additive Petition, Safe Use of Color Index C.I. Pigment Violet 19, C.I. Pigment Yellow 154, and C.I. Pigment Red 122 as Color Additives in Contact Lenses (New 8/31/05)

Laser Light Show (New 11/14/05)

Determine That the Drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg Tablets (NDA 07-935) Was Voluntarily Withdrawn From Sale for Reasons Other Than Safety or Effectiveness (New 8/11/06)

Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants (Updated 06/13/06)

Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease (New 8/3/05)

Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup (Updated 7/27/06)

Laser Light Show (New 10/6/05)

FDA to refuse to approve ANDA or Section 505(b)(2),for inhalation Drug Products Containing a Combination of the Active Ingredients Albuterol Sulfate and Ipratropium Hydrochloirde Administered by Nebulization for the Treatment of Chronic Pulmonary Obstructive Disorder (New 3/7/07)

Projector for a Laser Light Show (New 11/14/05)

Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability (New 5/25/06)

Current Good Manufacturing Practice Regulation and Investigational New Drugs (Updated 6/13/06)

Require Health Messages on Soft Drinks (Updated 1/23/06)

Laser Light Show (New 11/14/05)

Projector for a Laser Light Show (New 11/14/05)

Food Labeling; Gluten-Free Labeling of Foods; Public Meeting (Updated 12/27/05)

Add Calcium to the Mandatory List (Updated 12/28/05)

P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05 (New 9/15/05)

Amend 21 C.F.R. 101.12(b) Table 2 Reference Amount Customarily Consumed Per Eating Occasion: General Food Supply, by Establishing a Separate Reference Amount for Fruitcake of 43 Grams (1 1/2 ounces) (Updated 03/16/07)

Projector for a Laser Light Show (New 7/14/05)

Remove from the Labeling for Propofol (Diprivan) the Warning that Propofol should be Administered Only by Persons Trained in the Administration of General Anesthesia, Rather than by Other Qualified Medical Professionals (Updated 12/22/05)

Laser Light Show (Updated 11/14/05)

Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program (Updated 9/29/06)

Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry (New 8/18/05)

Laser Light Show (Updated 11/14/05)

Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331 (New 7/6/05)

Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is Suitable for Submission as an ANDA (New 7/6/05)

Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634 (New 05/22/2006)

Determine that Decadron (dexamethasone USP) 1.5 mg Tablet Strength was not Removed from the Market for Safety and Efficacy Reasons (New 1/23/06)

ANDA for a Sterile Vancomycin Hydrochloirde,USP Bulk Package in 100 gram Dosage Strength in Plasti Bags (New 8/30/05)

P040026 - Orthospec Extracorporeal Shock Wave Therapy Device, Approved 4/1/05 (New 9/15/05)

Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability (Updated 12/28/05)

Re-Listing Petition to Determine that Two Strenghths, 50 mg and 250 mg Lamotrigene Oral Tablets, were not Withdrawn Due to Safety nor Efficacy Concerns (New 1/3/06)

Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,912,246 (New 6/24/05)

Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927 (Updated 5/22/06)

Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698 (New 6/24/05)

Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077 (New 6/24/05)

Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability (Updated 10/4/05)

Laser Light Show (New 11/14/05)

Mobile Laser Show (New 11/14/05)

Update on Leukocyte Reduction of Blood and Blood Components; Public Workshop (New 7/6/05)

Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability (New 10/4/05)

Laser Light Show (New 11/15/05)

Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals (New 7/6/05)

FDA Vision 2006: A Conversation with the American Public (New 8/29/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program (New 8/29/05)

To Change the Classification of EEG Electrode Scurrently Classified as Class II and Requiring 510K Approvals (Updated 9/14/06)

ANDA Suitability Petition for Lamotrigine 50 milligram and 250 milligram Oral Tablets (New 6/27/05)

Health Claim Notification: Whole Grains and Coronary Heart Disease (New 6/7/05)

Change in Classification for Sonomet Body Compition Analyzer, BOD POD and PEAPOD (Updated 11/20/07)

Laser Light Show (New 5/31/05)

Revise Drug Labeling for Adverse Event of Tendonopathy and Tendon Rupture (New 5/31/05)

Deny the Pre-market Approval Applications of Mentor Corporation and Inamed Corporation for Approval of Silicone-gel Filled Breast Implant Products (Updated 11/20/06)

Guidance for Industry on Safety Testing of Drug Metabolites (Updated 8/17/05)

Guidance for Industry on Bar Code Label Requirements; Questions and Answers (Updated 5/10/06)

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products (New 6/1/05)

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (VICH GL-39) (New 6/1/05)

Projector for a Laser Light Show (Updated 6/20/06)

Laser Light Show (New 5/24/05)

Determine that Pantoprazole Sodium Injection 40 MG per Vial is Suitable for Submission as an Abbreviated New Drug Application (New 5/26/05)

Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9 (Updated 9/21/05)

Laser Light Show (New 5/23/05)

P030037 - Rithron-XR Coronary Stent System (Updated 9/15/05)

P040016 - Boston Scientific Corporation Liberte Monorail and Over-the-wire Coronary Stent Systems (Updated 9/15/05)

P040034 - Duraseal Sealant System (Updated 9/15/05)

Nutrient Content Claims: ALA and DHA Omega-3 Fatty Acids (New 5/23/05)

Laser Light Show (New 6/20/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications (New 10/5/05)

Precursor Preference in Surfactant Synthesis of Newborns (Updated 6/21/05)

Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency (Updated 8/17/05)

Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA (New 5/25/06)

Laser Light Show (New 6/20/05)

ANDA Suitability for Hydrocodone Bitartrate and Ibuprofen Tablets in the Following Strength, 2.5 MG/ 200 MG (New 5/19/05)

ANDA Suitability for Ribavirin, USP Tablets in a Strength of 500 MG (Updated 7/26/07)

Projector for a Laser Light Show (New 11/15/05)

Make a Determination that Cefitoren Pivoxil Tablets, 400 MG is Suitable for Submission in an ANDA (New 5/19/05)

Guidance on Expiration Dating of Unit-Dose Repackaged Drugs (Updated 7/18/05)

Request Uniform Professional Labeling for Promethazine Hydrochloride Syrup, USP (New 5/19/05)

Laser Light Show (New 11/15/05)

Laser Light Show (New 11/15/05)

ANADA for a Generic Ivermectin Soft Chew that Differs in Dosage Form for Horses (New 5/19/05)

Color Additive Certification; Increase in Fees for Certification Services (New 6/7/05)

Guidance on Useful Written Consumer Medication Information (CMI) (Updated 8/17/05)

Determine Whether Aeroseb-dex (Descamethasone) Topical Aerosol, 0.01% (NDA 083-296) has been Voluntarily Withdrawn for Safety or Efficacy (New 5/19/05)

Require Celgene Corporation to Revise the Labeling of Thalomid Capsules to Strengthen Warnings of the Potential for Serious Adverse Events (New 5/19/05)

To Prevent the Unlawful Misbranding of Prescription Distance Glasses and Contact Lenses (Updated 2/23/07)

Projector for a Laser Light Show (New 5/23/05)

Laser Light Show (New 5/3/05)

Projector for a Laser Light Show (New 5/3/05)

ANDA Suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution, USP, 5 MG/ 0.05 MG/ 5 ML. (New 5/17/05)

ANDA Suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Tablets (New 5/17/05)

BioGenex Laboratories, Inc., Premarket Approval of InSite Her-2/neu kit, P040030; Approved 12/22/04 (New 9/15/05)

Ventana Medical Systems, Inc.; Premarket Approval of Ventana Medical Systems' Pathway Anti-c-KIT (9.7) Primary Antibody, P020055 (New 9/15/05)

Bayer Healthcare, LLC; Premarket approval for ADVIA Centaur HBc IgM ReadyPack Reagents and ADVIA Centaur HBc IgM Quality Control Materials, P030040 (New 9/16/05)

Permission to File an Abbreviated New Drug Application for Baclofen Oral Solution, 10 MG/5 ML (New 5/17/05)

Laser Display Device (New 5/11/05)

Laser Light Show (New 5/3/05)

P930016/S020 - STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS), Approved 3/17/05 (New 9/16/05)

To Establish Guidance or Regulations Providing Bioequivalence Requirement for Oral Locally-acting Gastrointestinal (GI) Drug Products Prior to Approval of any Generic Versions of Such Drugs (Updated 1/4/08)

Laser Light Show (New 5/23/05)

ANDA Suitability for Oxycodone Hydrochloride 20 MG/ML Oral Solution (Updated 6/13/06)

High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing (New 5/10/05)

Laser Light Show (New 5/11/05)

Laser Light Show (New 5/11/05)

ANDA Suitability for Oxycodone Hydrochloride, 7.5 MG Tablets, USP

Withdrawal of Approvals of Certain Herdwide/Flockwide Uses of Critically and Highly Important Antibiotics Pursuant to Guidance #152

Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting (New 8/31/05)

Concerning Marketing Exclusivity for Vitrase (NDA 21-64) (New 5/17/05)

Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection (New 6/2/05)

HDE Number: H030005, CoAxia Neuroflo Catheter

Request for an Advisory Opinion Concerning a 510(K) for a Medical or Dental Device (New 5/10/05)

P030052 - UroVysion Bladder Cancer Kit, Approved 1/24/05 (New 9/16/05)

Proposal to Disqualify Charles M Singleton, M.D.; Regulatory Hearing (New 5/19/05)

Abbreviated New Drug Applications (ANDAs) Referencing Arava (Leflunomide) Tablets (Updated 10/4/05)

Projector for a Laser Light Show (New 5/11/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content CLaim Based on an Authoritative Statement of a Scientific Body (New 5/3/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Need for Online Medical Device Information (New 8/10/06)

Guidance for Industry on Exploratory IND Studies (Updated 8/11/05)

Non-invasive Bone-Growth Stimulator be Reclassified from Class III to Class II (Updated 4/27/07)

Agency Information Collection Activities: Proposed Collection; Comment Request;Experimental Study of Carbohydrate Content Claims on Food Labels (New 8/31/05)

2005N-0119

Preparation for the International Conference on Harmonization Meetings in Brussels, Belgium: Public Meeting (New 5/26/05)

2005P-0116

To Take the Following Actions with Regard to Aqueous-based Drugs for Inhalation that has been Compounded by Pharmacy Operations (Updated 12/29/05)

2005P-0115

Immediately Remove from the Market Pemoline Cyler-Abbott Laboratories, and all Generic Versions, a Stimulant Drug for the Treatment of Attention Deficit Hyperactivity Disorder (New 5/17/05)

ANDA for Ceftriaxone for Injection, USP, Pharmacy Bulk Package in a 100 Gram Dosage Strength Packages in Plastic Bags that are Contained Within Foil Outer Wraps (New 5/17/05)

Preclinical and Clinical Trial Design for Cervical and Lumbar Disco Replacement Systems (New 4/4/05)

Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (Updated 7/13/05)

Laser Light Show (New 5/11/05)

Glycoprotein IIB/IIIA Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women (Updated 10/4/05)

Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment (New 7/14/05)

Determine Whether Peptavlon (Pentagastrin) was Voluntarily Withdrawn from Sale for Reasons Other than Safety or Effectiveness (New 5/17/05)

Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials (Updated 8/1/06)

Guidance: Non-Clinical Tests and Recommended Labelin for Intravascular Stents and Associated Delivery System (New 5/10/05)

Civil Money Penalty Complaint in the Matter of Gerald Dorros, M.D. (New 3/22/05)

ANDA 77-421 Loratadine Syrup-Hives Relief (New 5/17/05)

ANDA 505(B)(2) Application for any Generic Version or Other Pharmaceutical Alternative of VENOFER (Iron Sucrose Injection, USP) (Updated 01/24/07)

Remove the Drug Iressa (Gefitnib; Astrazeneca) from the Market Immediately (New 5/17/05)

Revoke Part of 5 CFR 5501.104(B)(3) Prohibits Ownership of Financial Interest in a Publicly Traded or Publicly Available Investment Funds (New 5/17/05)

P040006 - Charite Artificial Disc, Approved 10/26/04 (New 3/22/05)

Amend or Revoke 5 CFR 5501.010(C)(2) Based Upon a Review of the Basis, Intended Purpose and Actural Societal Needs (Updated 5/17/05)

P030030 - Uryxurethral Bulking Agent, Approved 12/16/04 (New 3/22/05)

Premarket Approval for Irvine Biomedical (P040014), IBI Thereapy Cardiac Ablation System (New 3/22/05)

Premarket Approval for Eastment Kodak Company ( P030007), Kodak Mammography CAD Engine (New 3/22/05)

Laser Light Show (New 5/11/05)

Provide a Generic Form of Endrate Disodium Injection, USP in Secondary Package Configurations of a Single Box Containing One Vial and or Trays Containing Twenty-five Vials Per Tray (Updated 5/31/05)

Commercial Brachytherapy Kits for Treatment of Prostate Cancer; Non-Absorbable Bone Wax; Non-Absorbable Reformulated "Faux Bone Wax" Needle Plugs (Updated 6/28/06)

Xanda Suitability for Prednisolone Sodium Phosphate Solution 10MG/5ML, 20 MG/5 ML and 25 MG/5 ML (Equivqalent Prednisolone Base) (Updated 5/17/05)

Determine Whether Vioxx Tablets, Manufactured by Merck has been Voluntarily Withdrawn or Withheld from Sale for Safety or Efficacy Reasons (New 3/8/05)

Laser Display Device (New 3/8/05)

Oxycontin and Paladone Removal from Market and Label Changes Limiting Indications to Severe Chronic Pain (Updated 5/23/05)

Chlorhexidine Gluconate 2% W/V and Isopropyl Acohol 70% V/V Patient Preoperative Skin Preparation 3 ML, in Different Dosage Form Suitable for ANDA (New 5/17/05)

Laser Light Show (New 5/11/05)

Withholdig of Safety Information Regarding Risks of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Ibuprofen Products (Updated 7/28/06)

ANDA Suitability for Oral Salmon Calcitonin (New 5/16/05)

ANDA Suitability for Amlodipine Besylate Capsules 2.5, 5, and 10MG (Updated 7/18/05)

Request for Scientific Data and Information: Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish; and Evaluation of Food Code Provisions that Address Preventive Controls for Listeria monocytogenes in Retail and Foodservice Establishments (New 6/7/05)

Project for a Laser Light Show (New 5/11/05)

Draft Guidance FDAs Drug Watch for Emerging Drug Safety (Updated 8/30/05)

Determine Wheather the Listed Drug has been Withdrawn for Safety or Effectiveness Reasons (New 5/16/05)

Hydrochlorothiazide Tablets 12.5 MG, is Suitable for Submission in an ANDA (New 5/19/05)

Reviewer Guidance on Conducting a Clinical Safety Review of A New Product Application and Preparing a Report on the Review; Availability (New 3/15/05)

Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/PS) (New 5/6/05)

Laser Light Show (New 2/17/05)

Projector for a Laser Light Show (New 2/17/05)

Projector for a Laser Light Show (New 2/17/05)

ANDA Suitability for Colistimethate Sodium 150 MG/2 ML Solution (New 2/17/05)

Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability (New 3/14/05)

Professional Labeling for Aspirin Dosing In Order to Specificy the More Favorable Benefit/Risk Profile of Aspirin Doses of 75 - 150 MG/Day for Secondary Cardiovascular Prevention, 5-=150 MG/Day for Secondary Cerebrovascular Prevention (Udated 12/29/05)

Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (Updated 11/12/07)

Removal of Patent Listings by Reinserting the Info in the Orange Book and Maintain the Listing Until Ranbaxy's Term of Exclusivity has Elapsed (Updated 7/28/06)

ANDA Suitability for Chlorozoxazone Tablets USP, 375 MG (New 5/16/05)

Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy; Draft Revised Compliance Policy Guide (New 3/15/05)

Draft Guidance on the Open Public Hearing, FDA Advisory Committee Meetings (Updated 7/6/05)

Projector for a Laser Light Show (New 2/16/05)

Authorization of Emergency Use of Anthrax Vaccine Adxorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack with Antrax (New 2/17/05)

To Issue an Advisory Opinion with Respect to Agency Limitations Durig Inspection of or Inquiries to Devices Manufacturers Whose Facilities are Located Outside the Jurisdiction of the US (New 2/16/05)

Reporting of Adverse Events to Institutional Review Boards; Public Hearing (Updated 7/13/05)

Regarding Product of Estradiol Vaginal Cream (New 2/16/05)

Authorizing Phelon Parts, Inc., to Purchase and Use Nitrous Oxide Gas As Part of the Manufacturing Process of the Phelon Group (New 2/16/05)

Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market (Updated 5/16/05)

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, process Filing and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers (New 5/3/05)

Guidance for Industry on Clinical Lactation Studies Study Design, Data Analysis, and Recommendations for Labeling (New 5/10/05)

P030034 - Cervical-Stim Model 505L Cervical Fusion System (New 2/16/05)

P030034 - Reflection Ceramic Acetabular System (New 2/16/05)

ARTISAN (Model 206 and 204) Phakic Intraocular Lens (PIOL) Verisyse (VERSM5US and VRSM6US) Phakic Intraocular Lens (New 2/16/05)

P030029 - ADVIA Centaur Anti-HBs ReadyPack Reagents and ADVIA Centaur Anti-HBs ReadyPack Calibrators (New 2/16/05)

P010058 - OSTEOSPACE (New 2/16/05)

Determine if Tequin Injection 10MG/ML (200MG)- 20 ML Was Withdrawn for Safety or Effectiveness Reasons (New 2/16/05)

International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals (New 7/11/05)

International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development (Updated 7/13/05)

Replace Inacurate and/or Misleading Wording as Unpasteurized and Replace with the Word Untreated (New 5/16/05)

Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation PRI (New 5/10/05)

Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle (New 8/30/05)

Request for Advisory Opinion Concerning "Orange Book" Listing of Patents (New 2/17/05)

Regarding Hip Joint Metal Constrained (New 2/17/05)

Cefixime for Oral Suspension, 200 MG/ML, as an Abbreviated New Drug Application (ANDA) (New 5/11/05)

Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products (New 5/10/06)

High Chemical Co. et. al., Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing (New 5/10/05)

Projector for a Laser Light Show (New 2/17/05)

Simvastatin Tablets 5MG, 10MG, 20MG, and 40 MG (Updated 7/28/06)

ANDA Suitability for Risperidone Orally Disintegrating Tablets, 0.25 MG (Updated 5/11/05)

ANDA Suitability Petition for Bumethanide Injection, USP 10MG/40 ML (New 2/16/05)

Guidance for Industry on Nonclinical Safety Evaulation of Drug Combinations (Updated 5/6/05)

Laser Light Show (New 2/16/05)